Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immune Reconstitution in HIV Disease (IREHIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Karolinska Institutet
Sponsor:
Collaborators:
Addis Ababa University
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
Information provided by (Responsible Party):
Susanna Brighenti, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01702974
First received: September 25, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.


Condition Intervention Phase
HIV Infection
Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Drug: Placebo tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • HIV viral load [ Time Frame: 0 (baseline) compared to 16 weeks. ] [ Designated as safety issue: Yes ]
    Plasma HIV viral load will be used to monitor efficacy of vitamin D and phenylbutyrate treatment among treatment-naïve HIV patients at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at 16 weeks compared to baseline (time point 0).


Secondary Outcome Measures:
  • Clinical secondary endpoints [ Time Frame: 0, 4, 8, 16, 24 weeks. ] [ Designated as safety issue: Yes ]

    Overall clinical symptoms.

    Body mass index (BMI).

    Mid upper arm circumference (MUAC).


  • Laboratory secondary endpoints [ Time Frame: 0, 4, 8, 16, 24 weeks. ] [ Designated as safety issue: Yes ]

    HIV viral load (0, 4, 8, 24 weeks).

    Peripheral CD4/CD8 T cell counts.

    Plasma levels of vitamin D, LL-37, sCD14, LPS, 16S RNA and cytokine/chemokine profiles.

    Calprotectin in feces.

    Inflammation and microbial translocation in colon punch biopsies (0 and 16 weeks).

    Functional studies of immune cells (PBMCs).



Other Outcome Measures:
  • Interim analysis [ Designated as safety issue: Yes ]
    An interim analysis will be performed after approx. 75-100 patients have been included into the study.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
Drug: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
Placebo Comparator: Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Drug: Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients >18 years not subjected to HAART.

HIV-1 infected patients with CD4 T cells counts >200 cells/ml.

Detectable plasma viral loads >5000 copies/ml.

Exclusion Criteria:

Patients on HAART or other antimicrobial drugs (including bactrim).

Antimicrobial drug treatment in the past month.

Patients with medical contra-indication for biopsy such as bleeding tendencies.

Hypercalcaemia (serum calcium > 2.6 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702974

Contacts
Contact: Wondwossen Amogne, MD 251-911406179 wonamogne@yahoo.com
Contact: Endale Kassa, MD 251-911228562 endalekassalulu@gmail.com

Locations
Ethiopia
Black Lion Hospital (BLH), Addis Ababa University, Faculty of Medicine Recruiting
Addis Ababa, Lideta sub city, Ethiopia
Contact: Wondwossen Amogne, MD    251-911406179    wonamogne@yahoo.com   
Principal Investigator: Wondwossen Amogne, MD         
Principal Investigator: Endale Kassa, MD         
Sponsors and Collaborators
Karolinska Institutet
Addis Ababa University
Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia
Investigators
Principal Investigator: Susanna Brighenti, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Susanna Brighenti, Assistant professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01702974     History of Changes
Other Study ID Numbers: IREHIV-2012
Study First Received: September 25, 2012
Last Updated: October 8, 2012
Health Authority: Ethiopia: Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA)

Keywords provided by Karolinska Institutet:
HIV
cholecalciferol
sodium phenylbutyrate
antimicrobial peptides
immune response
inflammation

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
4-phenylbutyric acid
Anti-Infective Agents
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Antineoplastic Agents
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014